Sold by: SPK and AssociatesÂ
Accelerate your medical device innovation with SPK and Associates Medical Cloud Device Compliance Consulting Services. Leverage AWS services such as EC2 to support Computer System Validation, align with FDA guidelines, and ensure your products meet regulatory standards while speeding time to market.
Overview
SPK and Associates offers Medical Device Compliance Consulting Services designed to help you navigate the evolving landscape of regulatory requirements. Our experts specialize in aligning cloud-based infrastructure using AWS services, including EC2, to support FDA-compliant Computer System Validation and modern Computer Software Assurance practices. We provide guidance on regulatory strategy, documentation, quality management system implementation, and team training to ensure your organization meets the expectations of the FDA and global markets. Whether you are building a new product or modernizing existing systems, our consulting services transform compliance efforts into strategic advantages, helping your medical devices meet and exceed rigorous industry standards.
Highlights
- Expert Guidance: Receive comprehensive support from industry experts with extensive experience in FDA and international regulatory compliance.
- End-to-End Solutions: Benefit from a full spectrum of compliance services from initial strategy development to post-market surveillance.
- Accelerated Market Access: Fast-track your product journey to the market with our streamlined compliance processes and insights into regulatory pathways.
Details
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Delivery method
Deployed on AWS
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Pricing
Custom pricing options
Pricing is based on your specific requirements and eligibility. To get a custom quote for your needs, request a private offer.
Legal
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Support
Vendor support
As a consulting partner within the Amazon Partner Network, SPK is a leading Engineering & IT services provider that helps customers accelerate their product to market more quickly. Support plans range from 24x7x365 to business hours. Contact SPK directly for details -